Non-invasive Ventilation With NAVA in Infants With Severe Bronchiolitis. A Multicenter Pilot Open Label Pragmatic Randomized Controlled Trial (NAVIGATE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Recruitment rate
研究概览
简要总结
Severe bronchiolitis is a common lung infection in babies that can cause serious breathing problems and often leads to hospitalization in pediatric intensive care units (PICUs). Many infants need special breathing support, usually through non-invasive methods like high-flow oxygen or continuous airway pressure. However, these methods don't always work, and about one in four infants end up needing a breathing tube (intubation), which comes with more risks and a longer recovery.
A newer breathing support method called NIV-NAVA (non-invasive ventilation with neurally adjusted ventilatory assist) may help. It uses signals from the baby's diaphragm to adjust the support in real-time, making breathing easier and possibly reducing the need for intubation. While early results are promising, no high-quality clinical trial has yet tested if NIV-NAVA is better than standard non-invasive support.
This study is a pilot trial - a small-scale version of a larger future study - happening in four PICUs across Canada. It will include 90 babies under 2 years old with severe bronchiolitis who need more support than standard methods provide. Half will receive NIV-NAVA, and half will receive the usual care.
The main goal of this pilot is to check if a larger trial is doable: Can we recruit enough babies? Can the PICU teams stick to the treatment plan? Can we collect the right information? The full study will eventually look at whether NIV-NAVA really lowers the number of babies who need intubation and improves recovery.
This research is led by a team of pediatric experts and could pave the way for better care for thousands of infants with severe breathing problems.
详细描述
Goal(s) / Research Aims The primary objective of this multicenter pilot RCT is to determine the feasibility of a definitive multicenter RCT that will evaluate whether NIV-NAVA is superior to conventional NIV in infants with severe bronchiolitis who are not adequately supported by HFNC or CPAP. The primary hypothesis is that the pilot RCT will confirm the feasibility of the final trial.
Methods / Approaches This is an investigator-led, multicenter, randomized, controlled, open-label, pragmatic pilot trial conducted in four Canadian pediatric intensive care units (PICUs) with varying levels of experience with NIV-NAVA, supported by the Canadian Critical Care Trials Group (CCCTG).
Ninety infants younger than 2 years old who are admitted to the PICU with a clinical diagnosis of bronchiolitis, who require NIV support greater than CPAP/HFNC, and who have no exclusion criteria will be randomized 1:1 between NIV-NAVA and conventional NIV management.
The pilot trial's feasibility outcomes are the recruitment rate (the primary outcome), adherence to the intervention, and completion of the definitive trial's outcome measures. The primary outcome of the future definitive RCT is the intubation rate. Secondary outcomes will include respiratory distress evolution, comfort, duration of ventilatory support, PICU and hospital length of stay, nutrition and sedation, complication rates, post-PICU functional outcomes, carbon footprint, and cost-effectiveness analysis.
Expertise. An experienced, multidisciplinary team of senior, mid, and early career clinician scientists with unique expertise in pediatric NIV, trial methodology, pediatric respirology, and PICU research is leading this project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants younger than 2 years old
- •admitted to the PICU (or managed by the PICU team while awaiting PICU admission)
- •with a clinical diagnosis of bronchiolitis according to the treating team
- •requiring NIV support higher than CPAP/HFNC according to the treating team, a criteria present for less than 8 hours.
排除标准
- •imminent intubation criteria
- •refusal by the physician in charge
- •chronic home ventilation
- •hemodynamic instability requiring vasopressors
- •contraindication to NIV or to gastric tube insertion
- •patients in whom a limitation of life-support treatment is considered
研究组 & 干预措施
NIV-NAVA arm
Installation of an Edi catheter. Ventilation with NIV-NAVA as long as a bi-level NIV support is needed.
干预措施: NIV NAVA (Device)
Control arm (usual care)
Ventilation according to the clinical team. No NAVA ventilation allowed.
结局指标
主要结局
Recruitment rate
时间窗: from initiation to the end of the 6-month study enrolment period
% of eligible patients (identified by screening) who are included in the study at each site and overall
次要结局
- Capacity to assess the evolution at 3 months post PICU(3 months post PICU discharge)
- adherence to the intervention(during the NIV support period, starting from randomization to the end of the bi-level support NIV (=no NIV-NAVA or BIPAP for at least 48 hours), up to a maximum of 28 days)
- completion of the definitive trial outcomes(from initiation to the end of the 6-month study enrolment period)
- Evolution of the respiratory distress mWCAS score(at randomization, and after 2, 6, and 24 hours)
- Evolution of the respiratory distress ROX-HR score(at randomization, and after 2, 6, and 24 hours)
- Evolution of the comfort score(at randomization, and after 2, 6, and 24 hours)
研究者
Dr Guillaume Emeriaud
Professor
St. Justine's Hospital